Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations

ConditionsNon-Small Cell Lung Cancer EGFR Sensitive Mutation Adjuvant Therapy

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorBetta Pharmaceuticals Co., Ltd.

About this trial

This multicenter, randomized, controlled, double-blind, double-simulated, Phase III study is designed to evaluate the efficacy and safety of Befotertinib compared with Icotinib as adjuvant treatment in EGFR-sensitive mutation-positive stage IB-IIIB (T3N2M0) non-small cell lung cancer after surgical resection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willingness to sign informed consent prior to any study specific procedures, and ability to with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Male or female, aged at least 18 years.

Histologically confirmed primary NSCLC, and mainly non-squamous cell carcinoma (including mixed type carcinoma mainly composed of adenocarcinoma components).

Absence of brain metastasis.

Disqualifiers

There are unresectable or metastatic diseases, pathological reports showing positive surgical margins under the microscope or extranodal invasion, or lesions left after surgery, or suspicious lesions determined by imaging after surgery. Subjects receiving only wedge resection.

Upper lung groove cancer.

Patient with complete resection of the right lung with NSCLC.

Malignancies other than NSCLC within 5 years prior to first dosage, except for malignant tumors that can be cured after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery).

Trial design

Design model

Parallel

Treatments tested in this trial

Befotertinib + Icotinib placebo
Drug
The initial dose of Befotertinib is 75 mg orally once daily (QD) for 21 days, and then increased to 100 mg orally QD in the absence of serious side effects , CTCAE grade ≥ 2 headache or thrombocytopenia during the 21 days. Befotertinib can be taken on an empty stomach or after meals, and the medication is used until the disease relapses or intolerable toxicity occurs, or the treatment lasts for 3 years (disease recurrence includes local recurrence and/or distant metastasis) Icotinib placebo 125 mg three times daily, on an empty stomach or in combination with food, use medication until the disease relapses or intolerable toxicity occurs or treatment lasts for 2 years (disease recurrence includes local recurrence and/or distant metastasis).
Icotinib + Befotertinib placebo
Drug
Icotinib 125 mg three times daily, on an empty stomach or in combination with food, use medication until the disease relapses or intolerable toxicity occurs or treatment lasts for 2 years (disease recurrence includes local recurrence and/or distant metastasis). The initial dose of Befotertinib placebo is 75 mg orally once daily (QD) for 21 days, and then increased to 100 mg orally QD in the absence of serious side effects , CTCAE grade ≥ 2 headache or thrombocytopenia during the 21 days. Befotertinib placebo can be taken on an empty stomach or after meals, and the medication is used until the disease relapses or intolerable toxicity occurs, or the treatment lasts for 3 years (disease recurrence includes local recurrence and/or distant metastasis.

Treatment groups

570 Participants

are divided into 2 treatment groups

Group A: Befotertinib + Icotinib placeboExperimental treatment 1 intervention

Group B: Icotinib + Befotertinib placeboActive comparator 1 intervention

Trial outcomes

Primary outcomes

Disease free survival (DFS) evaluated by investigator in patients with stage II-IIIB (T3N2M0)

Time frame

up to 5 years

Secondary outcomes

DFS evaluated by investigator in patients with stage IB-IIIB (T3N2M0)

Time frame

up to 5 years

Other outcomes

DFS rate at 2 years

Time frame

Assessed at 2 years

DFS rate at 3 years

Time frame

Assessed at 3 years

DFS rate at 5 years

Time frame

Assessed at 5 years

Overall survival (OS)

Time frame

Assessed at 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Betta Pharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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